Clinical Trial: Comparing Buccal and Vaginal Misoprostol in Management of Early Pregnancy Loss

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Comparing Buccal and Vaginal Misoprostol in Management of Early Pregnancy Loss: a Pilot Randomized Controlled Trial

Brief Summary: First trimester miscarriages are common. When the failed pregnancy does not pass spontaneously on its own, it is called a missed abortion. There are several ways in which missed abortions are managed, one of which involves administering a medication called misoprostol which causes uterine contractions inducing expulsion of the failed pregnancy. Misoprostol can be administered in multiple ways but has been traditionally inserted vaginally when used for management of missed abortions. Some studies have shown that some women are not comfortable with vaginal insertion of misoprostol and prefer oral administration. Buccal misoprostol is a way of administering misoprostol by having the patients insert the tablets of misoprostol between their gum and cheek, letting it dissolve for 30 minutes, then swallowing the remaining remnants. Buccal misoprostol is used safely in medical abortion. In fact a study by Fjerstad et al (2009), found a decrease in infection rate for medical abortion when misoprostol administration was switched from vaginal to buccal route combined with routine administration of doxycycline. The efficacy of using buccal misoprostol to treat missed abortions has not been studied previously to the investigators' knowledge. In this pilot study, investigators aim to test the hypotheses that buccal misoprostol is equally effective as vaginal misoprostol in the medical management of early pregnancy loss. As secondary outcomes, investigators suspect that buccal misoprostol may be associated with higher rates of gastrointestinal side effect but that patient satisfaction will remain equally as high for buccal misoprostol as for vaginal misoprostol.

Detailed Summary:

Randomization:

Women who present to UCSD Medical Offices South clinic for evaluation and management of missed abortion will all be sent to the lab prior to the clinic visit for a type and screen and hemogram to determine blood type and hemoglobin level as is the current standard of care. Each woman will then be screened by a physician. The physician will notify a co-investigator of eligible patients who are interested in participating in the study. The co-investigator will consent the patient for the study. Once the written consent is obtained, patient will be asked to fill out an intake survey to obtain demographic information. Participants will be randomized into either the vaginal or buccal misoprostol group with a block size of four. Assignments will be concealed in sequentially numbered sealed opaque envelope. The envelope will be opened by the co-investigator who will reveal the route of misoprostol to the patient and review the written instructions on how to take the medication appropriately. Given the different routes of administration, neither the patient nor the provider will be blinded. Given that one of the secondary outcomes of interest was patient satisfaction based on the different route of administration, decision was made to not use placebo pills which could have been used to do a double-blinded study.

Intervention:

Dose of Misoprostol for both treatment groups: 800 micrograms administered as four tablets of 200 micrograms.

Currently, the standard of care is to prescribe vaginal misoprostol 800 mcg for women with an early pregnancy failure desiring medical management. The only "intervention" in this study is to change the route of administration from vaginal to buccal for the women randomized to th
Sponsor: University of California, San Diego

Current Primary Outcome: Patient enrollment [ Time Frame: One year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Complete abortion [ Time Frame: one week ]
  Complete abortion without surgical intervention defined as no evidence of a gestational sac on transvaginal ultrasound at the follow up visit.
• Patient satisfaction [ Time Frame: one week ]
  Written surveys patients will fill out at follow up visit assessing patient's satisfaction
• Medication side effects [ Time Frame: one week ]
  Assessment of medication side effects including: nausea, vomiting, headache, fever (> 100.4 F), dizziness, diarrhea, bad taste, dry mouth

Original Secondary Outcome: Same as current

Information By: University of California, San Diego

Dates:
Date Received: May 10, 2014
Date Started: July 2014
Date Completion: June 2015
Last Updated: May 14, 2014
Last Verified: May 2014